Actively Recruiting
A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-05
58
Participants Needed
3
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying calderasib (MK-1084) to understand how its levels change over time in the body, focusing on both people with liver (hepatic) impairment and healthy volunteers. The study also aims to learn about the safety and tolerance of MK-1084 in those with liver impairment. This is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC. All participants will receive a single oral dose of calderasib on the first day of the study. The trial involves measuring calderasib levels at specific times up to about 7 days after dosing to analyze how the drug is processed in the body. Researchers will look at various pharmacokinetic measures such as drug concentration, clearance, and half-life. Participants will be closely monitored through blood sampling and assessments to measure drug levels and safety up to approximately 14 days after the dose. The study will record any adverse events and track whether participants discontinue due to side effects. Overall participation time and follow-up will cover up to two weeks after dosing, focusing on how the drug behaves and is tolerated in people with and without liver impairment.
CONDITIONS
Brief Title
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 18 and 80 years old
- Participants must have a body mass index (BMI) between 18.0 and 42.0 kg/m^2
- Participants with hepatic impairment must have a diagnosis of chronic, stable hepatic insufficiency with features of cirrhosis
- Healthy volunteers must be medically healthy with no clinically significant medical history
You will not qualify if you...
- History of gastrointestinal disease affecting food or drug absorption
- History of cancer (malignancy)
- Positive test for human immunodeficiency virus (HIV)
- Major surgery or significant blood loss within 56 days prior to dosing
- For hepatic impairment participants: severe liver disease complications within 3 months before screening
- Recent variceal bleeds within 3 months prior to screening
- Evidence of hepatorenal syndrome
- Anticipated survival less than 3 months due to liver impairment
- History of liver or other solid organ transplantation
- Active infection requiring systemic therapy
- Requires paracentesis more than twice per month
- Has transjugular intrahepatic portosystemic shunt or portacaval shunting
- Recent antiviral or immune therapy for hepatitis B or C within 90 days before dosing
- Use of HIV protease inhibitors
- Positive for Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Healthy volunteers positive for HBsAg or HCV
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 days
Participants receive a single oral dose of Calderasib and are monitored for drug effects.
Multiple visits for pharmacokinetic sampling up to 7 days post-dose
Duration - Up to approximately 14 days
Participants are monitored for safety and adverse events up to approximately 14 days after dosing.
Visits as needed for safety assessments
Trial Site Locations
Total: 3 locations
1
Arizona Clinical Trials ( Site 0003)
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States, 32809
Actively Recruiting
3
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
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Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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